NCT06061393

Brief Summary

The purpose of this study is to compare maternal outcomes such as increased hemoglobin need for blood transfusion and hemoglobin level before and post partum in women with hemoglobin \<9 gr/dl , treated with venofer and women treated with ferinject.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Oct 2023

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 24, 2023

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 29, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

October 30, 2023

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 20, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 20, 2025

Completed
Last Updated

October 6, 2023

Status Verified

October 1, 2023

Enrollment Period

1.9 years

First QC Date

September 24, 2023

Last Update Submit

October 4, 2023

Conditions

Anemia, Iron DeficiencyPregnancy Anemia

Outcome Measures

Primary Outcomes (2)

  • ratio of women with Hb level >11 at delivery

    Hb level

    at delivery

  • postpartum Hb level

    gr/dl

    during 48 hours after delivery

Study Arms (2)

venofer

ACTIVE COMPARATOR

Women with iron def. anemia aith hemoglobin level \<9 gr/dl who will be traeted with venofer

Drug: Venofer 200 MG Per 10 ML Injection

Ferinject

ACTIVE COMPARATOR

Women with iron def. anemia aith hemoglobin level \<9 gr/dl who will be traeted with ferinject

Drug: Ferinject

Interventions

Venofer 200 MG Per 10 ML InjectionDRUG

treat anemia with venofer up to 5 doses

venofer
FerinjectDRUG

ferinject 500 mg, once a week for 2 weeks

Ferinject

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailspregnant women
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • pregnancy\>24 weeks of gestation anemia with Hb\<8 anemia with Hb\<9 if symptomatic anemia of previous postpartum hemorrhage

You may not qualify if:

  • Allergy to one of the study's drugs
  • IV iron treatment in the last month
  • chronic anemia- thalassemia, renal failure Twins pregnancy
  • non iron deficiency anemia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Anemia, Iron-Deficiency

Interventions

Ferric Oxide, SaccharatedInjectionsferric carboxymaltose

Condition Hierarchy (Ancestors)

Anemia, HypochromicAnemiaHematologic DiseasesHemic and Lymphatic DiseasesIron DeficienciesIron Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Ferric CompoundsIron CompoundsInorganic ChemicalsGlucaric AcidSugar AcidsAcids, AcyclicCarboxylic AcidsOrganic ChemicalsHydroxy AcidsCarbohydratesDrug Administration RoutesDrug TherapyTherapeutics

Central Study Contacts

maya Wolf, MD

CONTACT

972507887800mayaw@gmc.gov.il

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator.

Study Record Dates

First Submitted

September 24, 2023

First Posted

September 29, 2023

Study Start

October 30, 2023

Primary Completion

September 20, 2025

Study Completion

September 20, 2025

Last Updated

October 6, 2023

Record last verified: 2023-10